Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders

Heidelberg University

Status and phase: Completed; Phase 2

Conditions: Craniomandibular Dysfunction; Orofacial Pain

Treatments: Device: Michigan-type occlusal splint; Device: Grindcare

Study type: Interventional

Funder types: Other

Identifiers

NCT01949064

BioGC1UHeidelberg

Details and patient eligibility

About

The treatment of craniomandibular disorders is a challenging task. Many different treatments are yet available with occlusal splints being one of the most commonly used. A relative new diagnostic and treatment alternative is the Grindcare device. This enables the electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a certain limit. This stimulation results to a sudden break of the muscle activity.

Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our null-hypothesis was that there is no difference between the device and the splint in the reduction of pain intensity.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent form
• Age between 18 and 70 years
• Non-chronic painful CMD with/without mandibular movement restriction
• Female

Exclusion criteria

• Pregnancy or breastfeeding
• Chronic Pain Status higher than 2
• Known allergic reaction against the gel pads
• Electronic implants (pacemaker, defibrilator, insulin pump)
• Facial pain of dental or neuropathic etiology
• Traumatic injuries of the face / operations
• Dental treatment need
• Problems with swallowing reflex

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Michigan-type occlusal splint

Active Comparator group

Description:

Occlusal splint, Michigan-type

Treatment:

Device: Michigan-type occlusal splint

Grindcare

Active Comparator group

Description:

Biofeedback device

Treatment:

Device: Grindcare